Hemostemix Files for Ethics Approval of its Study of Vascular Dementia

Core Insights - Hemostemix has filed for ethics approval for a Phase 1 clinical trial of its stem-cell therapy, ACP-01, aimed at treating vascular dementia, a condition with no current cure [1][2][3] Industry Context - Vascular dementia (VaD) and vascular cognitive impairment (VCID) are the second most common causes of dementia globally, accounting for up to 20% of all dementia cases, highlighting a significant unmet medical need [3][4] - There are currently no FDA-approved therapies for VCID, positioning Hemostemix's trial as a pioneering effort in regenerative neuroscience [3] Company Overview - Hemostemix is advancing its autologous stem cell therapy platform, having previously demonstrated the safety and efficacy of ACP-01 in other conditions such as refractory angina and ischemic cardiomyopathy [5][26] - The company has completed seven clinical studies involving 318 subjects, with published results in eleven peer-reviewed journals, establishing a strong foundation for its current research [26] Clinical Trial Details - The Phase 1 study will evaluate the safety, feasibility, and preliminary efficacy of intrathecal administration of ACP-01 in patients aged 50 and older diagnosed with vascular cognitive impairment or vascular dementia [7][11] - The trial will include 20 to 100 participants, with a follow-up period of one year to monitor safety and cognitive improvements [16][11] Mechanism of Action - ACP-01 cells are derived from the patient's own blood and are designed to restore brain perfusion and neurovascular integrity by leveraging the body's natural signaling processes [20][21] - The direct intrathecal delivery method allows for better penetration to the brain, potentially enhancing the therapeutic effects compared to previous intravenous methods [21][22] Safety and Oversight - The clinical procedures will be conducted in an outpatient setting under the supervision of licensed neurosurgeons, with comprehensive safety monitoring by an independent Data Safety Monitoring Board [23][24] Executive Commentary - The President & CEO of Hemostemix emphasized that this filing represents a significant advancement in applying ACP-01's regenerative capabilities to address vascular dementia, a challenging medical condition [25]